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LABELS · 3921e23f-5c82-4e00-9611-f017ff57c06e

Ojjaara

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-07-20
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE OJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. ( 1 )
Full extracted label fields
application numbers
  1. NDA216873
boxed warning exact
    brand names
    1. Ojjaara
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a672fd1-eb7b-4aa9-9b23-845e4b5dc400
    generic names
    1. MOMELOTINIB
    id
    3921e23f-5c82-4e00-9611-f017ff57c06e
    indications and usage exact
    1. 1 INDICATIONS AND USAGE OJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. GlaxoSmithKline LLC
      matched search terms
      1. myelofibrosis
      2. polycythemia
      3. thrombocythemia
      package ndcs
      1. 81864-103-30
      2. 81864-102-30
      3. 81864-101-30
      product ndcs
      1. 81864-101
      2. 81864-103
      3. 81864-102
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Symptom Exacerbation Following Interruption or Discontinuation of Treatment ( 5.8 ) 3/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2665210
      2. 2665216
      3. 2665218
      4. 2665220
      5. 2665222
      6. 2665224
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00200.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      200
      total
      830
      sha256
      d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=200&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%223921e23f-5c82-4e00-9611-f017ff57c06e%22
      spl effective date
      2026-07-20
      spl effective time
      20260720
      spl set id
      4a672fd1-eb7b-4aa9-9b23-845e4b5dc400
      spl version
      9
      substance names
      1. MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
      uniis
      1. LDX8893L5D
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        NDA216873
        payload
        all indexed label documents
        1. Appl No
          216873
          Application Docs Date
          2023-09-18 00:00:00
          Application Docs ID
          75499
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          216873
          Application Docs Date
          2025-04-25 00:00:00
          Application Docs ID
          82000
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          216873
          Application Docs Date
          2026-03-24 00:00:00
          Application Docs ID
          85486
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          216873
          Application Docs Date
          2026-03-24 00:00:00
          Application Docs ID
          85487
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        5. Appl No
          216873
          Application Docs Date
          2026-07-30 00:00:00
          Application Docs ID
          86747
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          216873
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-09-15 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          216873
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2025-04-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          216873
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2026-03-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          216873
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2026-03-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          216873
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2026-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA216873
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-07-20
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          216873
          Application Docs Date
          2026-07-30 00:00:00
          Application Docs ID
          86747
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        official application record
        Appl No
        216873
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        GLAXOSMITHKLINE
        openfda application present
        true
        products
        1. Active Ingredient
          MOMELOTINIB DIHYDROCHLORIDE
          Appl No
          216873
          Drug Name
          OJJAARA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 100MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          MOMELOTINIB DIHYDROCHLORIDE
          Appl No
          216873
          Drug Name
          OJJAARA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 150MG BASE
          marketing status
          1. Prescription
        3. Active Ingredient
          MOMELOTINIB DIHYDROCHLORIDE
          Appl No
          216873
          Drug Name
          OJJAARA
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 200MG BASE
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA216873
      brand names
      1. Ojjaara
      classification reasons
      1. explicit_positive_indication_predicate
      2. supportive_or_complication_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      442
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE OJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombo
      label id
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      source text sha256
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      duplicate text group
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      extraction review status
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      generic names
      1. MOMELOTINIB
      id
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      label id
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      positive predicate support span
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      true
      exact text
      is indicated
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      qualifier mentions
      1. context exact
        emia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia.
        kind
        age
        polarity
        not_inferred
        span
        end
        229
        end exclusive
        true
        exact text
        adults
        label id
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        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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      regulatory links
        schema version
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        source batch sha256
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        source defined aliases
          source span
          end
          242
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE OJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia.
          label id
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          offset unit
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          source array index
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          source field
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          source text sha256
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          start
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%223921e23f-5c82-4e00-9611-f017ff57c06e%22
          spl effective date
          2026-07-20
          spl set id
          4a672fd1-eb7b-4aa9-9b23-845e4b5dc400
          spl version
          9
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          supportive_care_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA216873
          brand names
          1. Ojjaara
          classification reasons
          1. explicit_positive_indication_predicate
          2. supportive_or_complication_use_words
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          486
          end exclusive
          true
          exact text
          d for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. ( 1 )
          label id
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          current approval status
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          duplicate text group
          dup-ce8055ae36bef68e4feb
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. MOMELOTINIB
          id
          ind-span-b091a0a77e46ba291278
          label id
          3921e23f-5c82-4e00-9611-f017ff57c06e
          positive predicate support span
          end
          282
          end exclusive
          true
          exact text
          is a kinase inhibitor indicated
          label id
          3921e23f-5c82-4e00-9611-f017ff57c06e
          offset unit
          unicode_code_points
          source array index
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          source field
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          source text sha256
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          start
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          qualifier mentions
          1. context exact
            emia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia.
            kind
            age
            polarity
            not_inferred
            span
            end
            467
            end exclusive
            true
            exact text
            adults
            label id
            3921e23f-5c82-4e00-9611-f017ff57c06e
            offset unit
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            source array index
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            source field
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            source text sha256
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          regulatory links
            schema version
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            source defined aliases
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              end exclusive
              true
              exact text
              OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia.
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              source text sha256
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              source url
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              spl effective date
              2026-07-20
              spl set id
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              spl version
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              structured fields status
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              structured indication
              age
              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              supportive_care_candidate
              Passage 3 · unclassified context
              application numbers
              1. NDA216873
              brand names
              1. Ojjaara
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
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              content role
              unclassified_context
              context span
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              486
              end exclusive
              true
              exact text
              d for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. ( 1 )
              label id
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              offset unit
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              current approval status
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              duplicate text group
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              generic names
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              id
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              label id
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              positive predicate support span
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                    exact text
                    ( 1 )
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                    source url
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                    spl effective date
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                    spl set id
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                    spl version
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                    structured fields status
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                    structured indication
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                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear

                    Preserved source evidence · Not medical advice